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CAS number: 81103-11-9
Molecular formula: C38H69NO13
molecular weight: 747.9534
Chemical structure:
PRODUCT NAME |
CLARITHROMYCIN |
|
Shelf Life |
4 years |
|
ITEMS | SPECIFICATIONS | RESULTS |
APPEARANCE | WHITE TO ALMOST WHITE,CRYSTALLINE POWDER | COMPLIES |
SPECIFIC ROTATION | -94° TO -102°(20℃) | -96.9° |
IDENTIFICATION | IR SPECTRUM CORRESPONDS TO | COMPLIES |
CRYSTALLINITY | MEETS THE REQUIREMENTS | COMPLIES |
PH | 8.0-10.0 | 8.4 |
WATER | NOT MORE THAN 2.0% | 0.3% |
RESIDUE ON IGNITION | NOT MORE THAN 0.2% | 0.02% |
HEAVY METALS | NOT MORE THAN 20UG/G | COMPLIES |
PARTICLE SIZE | 40MESHES | COMPLIES |
RESIDUAL SOLVENTS | ETHANOL NOT MORE THAN 5000PPM | 300PPM |
PYRIDINE HYDROCHLORIDE SHOULD NOT DETECTED | ND | |
RELATED SUBSTANCES |
IMPURITY I NOT MORE THAN 1.0% |
ND |
IMPURITY A NOT MORE THAN 1.0% |
ND | |
IMPURITY J NOT MORE THAN 1.0% | ND | |
IMPURITY L NOT MORE THAN 1.0% | ND | |
IMPURITY B NOT MORE THAN 1.0% | ND | |
IMPURITY M NOT MORE THAN 1.0% |
0.06% |
|
IMPURITY C NOT MORE THAN 1.0% | ND | |
IMPURITY D NOT MORE THAN 1.0% | ND | |
IMPURITY N NOT MORE THAN 1.0% | ND | |
RELATED COMPOUND A NOT MORE THAN 1.0% |
ND | |
IMPURITY F NOT MORE THAN 1.0% |
0.27% |
|
IMPURITY P NOT MORE THAN 1.0% | ND | |
IMPURITY O NOT MORE THAN 1.0% | ND | |
IMPURITY K NOT MORE THAN 1.0% | ND | |
IMPURITY G NOT MORE THAN 1.0% | ND | |
IMPURITY H NOT MORE THAN 1.0% | ND | |
Any individual impurity not more than 1.0% |
0.6% |
|
Impurity exceed 0.4% not more than 4 |
2 |
|
Total impurities not more than 3.5% |
2.8% |
|
ASSAY | 96.0---102.0% ON ANHYDROUS BASIS | 97.7% |
CONCLUSION |
THIS BATCH OF PRODUCT IS IN CONFORMANCE WITH USP38 |